OBJECTIVE: The aim of this study was to test the effectiveness and safety of lamotrigine in maintenance of manic and depressive symptom control in pediatric bipolar disorder (PBD). METHODS: A 14-week open trial was conducted with 46 subjects presenting with mania or hypomania. Lamotrigine was slowly titrated to a therapeutic dose over an 8-week period, during which acute symptoms were stabilized using second-generation antipsychotics (SGA), followed by a 6-week lamotrigine monotherapy phase. RESULTS: The response rate on manic symptoms (Young Mania Rating Score [YMRS] <12) was 72%, on depressive symptoms was 82% (Children's Depression Rating Scale-Revised [CDRS-R] <40), and the remission rate was 56% at the 14-week end point, on an average end-point lamotrigine dose of 1.8 mg/lb. There was further reduction in depressive symptoms during the lamotrigine maintenance phase. Benign rash was noted in 6.4% of patients. Out of half of the subjects who were in remission at 8 week, 3 subjects (23%) relapsed by week 14. CONCLUSION:Lamotrigine monotherapy appears to be effective in maintaining symptom control of manic and depressive symptoms in PBD and shows minimal adverse effects, although a future double-blind controlled trial is needed to confirm this finding. Portal of entry for lamotrigine treatment can be during acute illness and can sustain symptom control after establishing mood stabilization.
RCT Entities:
OBJECTIVE: The aim of this study was to test the effectiveness and safety of lamotrigine in maintenance of manic and depressive symptom control in pediatric bipolar disorder (PBD). METHODS: A 14-week open trial was conducted with 46 subjects presenting with mania or hypomania. Lamotrigine was slowly titrated to a therapeutic dose over an 8-week period, during which acute symptoms were stabilized using second-generation antipsychotics (SGA), followed by a 6-week lamotrigine monotherapy phase. RESULTS: The response rate on manic symptoms (Young Mania Rating Score [YMRS] <12) was 72%, on depressive symptoms was 82% (Children's Depression Rating Scale-Revised [CDRS-R] <40), and the remission rate was 56% at the 14-week end point, on an average end-point lamotrigine dose of 1.8 mg/lb. There was further reduction in depressive symptoms during the lamotrigine maintenance phase. Benign rash was noted in 6.4% of patients. Out of half of the subjects who were in remission at 8 week, 3 subjects (23%) relapsed by week 14. CONCLUSION:Lamotrigine monotherapy appears to be effective in maintaining symptom control of manic and depressive symptoms in PBD and shows minimal adverse effects, although a future double-blind controlled trial is needed to confirm this finding. Portal of entry for lamotrigine treatment can be during acute illness and can sustain symptom control after establishing mood stabilization.
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